This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 3 of 581 for:    Recruiting, Not yet recruiting, Available Studies | "Substance-Related Disorders"

Women's Initiative Supporting Health Increasing Healthcare Access (WISH)

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by Diane Morse, University of Rochester
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Diane Morse, University of Rochester
ClinicalTrials.gov Identifier:
NCT02964845
First received: October 31, 2016
Last updated: November 10, 2016
Last verified: November 2016
  Purpose
Women recently released (RR women) from incarceration constitute a vulnerable group characterized by high rates of untreated HIV and sexually transmitted infections (STIs), substance use disorder (SUD), mental health (MH) disorders and trauma. This interconnected syndemic requires helping RR women to overcome multiple internal and structural care barriers. This R34 builds on work conducted by the PI in a NIDA-funded K23 project, in which an intervention called Women's Initiative Supporting Health (WISH) was developed to improve RR women's engagement in HIV, Hepatitis C (HCV), and primary medical care using Self Determination Theory (SDT). The proposed R34 project, a natural extension of this prior work, will conduct a pilot randomized controlled trial (RCT) of the WISH intervention to examine feasibility, acceptability, and preliminary effectiveness.

Condition Intervention
Substance-Related Disorders Behavioral: WISH with CHW and referral to HFM Other: Enhanced Treatment as Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Availability is Not Access:Recently Incarcerated Women, HIV Risk, and Substance Use Disorders

Resource links provided by NLM:


Further study details as provided by Diane Morse, University of Rochester:

Primary Outcome Measures:
  • Preliminary effectiveness of WISH to improve engagement in and adherence to needed treatments and associated outcomes [ Time Frame: 3 years ]
    The investigator will qualitatively analyze intervention/interview sessions using Atlas.ti to organize thematic content complemented by framework analysis. This is one assessment.


Secondary Outcome Measures:
  • Explore inflammation biomarkers outcomes of WISH [ Time Frame: 3 years ]
    The investigator will examine serum levels of IL-6.

  • Explore impact of WISH on inflammatory biomarker [ Time Frame: 3 years ]
    The investigator will examine serum levels of IL-8.

  • Explore biomarker levels in relation to intervention. [ Time Frame: 3 years ]
    The investigator will examine serum levels of D-dimer.

  • Explore serum levels of CRP [ Time Frame: 3 years ]
    The investigator will examine serum levels of CRP.

  • Linkage to HIV prevention services; HIV risk behaviors [ Time Frame: 3 years ]
    Success will be measured by demonstrated awareness of and willingness to participate.

  • Linkage to prevention program. [ Time Frame: 3 years ]
    Success will also be measured by if subjects made an HIV prevention appointment.

  • HIV prevention behaviors [ Time Frame: 3 years ]
    Adherence to HIV prevention strategies will be measured.

  • HIV risk behavior [ Time Frame: 3 years ]
    Changes in HIV risk behavior scale scores will also be measured.


Other Outcome Measures:
  • Substance Use Disorder treatment engagement [ Time Frame: 3 years ]
    The investigator will measure substance use as a behavioral and biological outcome.

  • Mental health treatment engagement [ Time Frame: 3 years ]
    The investigator will report initiation rate, engagement rate and number of services received after initiation as a singular measure for continuity of care.


Estimated Enrollment: 100
Study Start Date: July 2016
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WISH with CHW and referral to HFM
Subjects will be assigned a CHW for intervention sessions along with receiving primary care from Highland Family Medicine. CHWs will use the SDT-based, trauma-specific motivational approach in the intervention to engage women during 6 sessions. The duration of the intervention is 3 months. Each session will last 1 hour and will take place in a community location. CHW's will also help facilitate primary care by linking subjects to primary care and will use electronic records to update and receive input from medical providers, and support treatment recommendations from Trillium Health. CHWs will empower women to convey their needs to providers for HIV risk reduction, SUD, co-morbidity (MH, IPV) treatment and will support autonomy and competence for treatment in the intervention sessions.
Behavioral: WISH with CHW and referral to HFM
6 intervention counseling sessions with a peer CHW, as well as CHW facilitated linkage to primary care and HIV risk reduction.
Enhanced Treatment as Usual control
eTAU participants will be given an HIV risk reduction information sheet made in cooperation with Trillium Health, HIV health providers. The sheet will include sex and drug behavioral risk reduction strategies and information on obtaining PrEP. The eTAU group is also facilitated to receive healthcare by having a cell phone, a primary care clinic which accepts patients, and bus passes.
Other: Enhanced Treatment as Usual
Linkage to Primary care.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • English-speaking
  • >18 years old female by birth biologically
  • Any HIV risk and SUD in the year prior (adjusting for incarceration during which they may have had fewer HIV risk behaviors and less access to drugs or alcohol)
  • HIV/HCV negative
  • Released from incarceration within the prior 1 year or to be released within 2 weeks
  • Agree to release all medical/mental health/SUD treatment records for research access
  • Agree to become a patient at Highland Family Medicine for primary care

Exclusion Criteria:

  • Non-English speaking
  • < 18 year old
  • Not biologically female
  • Score <2 on the Six-Item Screener (derived from the Mini-Mental Status Examination )
  • Decline HIV/HCV assessment.
  • Refusal to obtain primary medical care from Highland Family Medicine.
  • The inability to speak or comprehend English with sufficient skill to give consent or understand interviewers.
  • Apparent intoxication; psychotic behavior or the presence of severe illness or pain that interferes with participation as determined with exclusion criteria score < 2 on the Six-Item Screener
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02964845

Contacts
Contact: Diane Morse, MD 585-275-6484 Diane_Morse@urmc.rochester.edu

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Diane Morse, MD    585-275-6484    Diane_Morse@urmc.rochester.edu   
Sponsors and Collaborators
University of Rochester
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Diane Morse, MD University of Rochester
Study Director: Addie Bardin, MBA University of Rochester
  More Information

Responsible Party: Diane Morse, Associate Professor of Psychiatry and Medicine, University of Rochester
ClinicalTrials.gov Identifier: NCT02964845     History of Changes
Other Study ID Numbers: RSRB#63032
1R34DA041240-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: October 31, 2016
Last Updated: November 10, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 23, 2017